Augmentation in Tx-resistant OCD: an Open Label Trial

This study has been completed.
Sponsor:
Collaborator:
Forest Laboratories
Information provided by:
Creighton University
ClinicalTrials.gov Identifier:
NCT00590642
First received: December 11, 2007
Last updated: November 27, 2009
Last verified: November 2009
  Purpose

This study examines the use of Acamprosate (Campral(R)) in the treatment of Obsessive Compulsive Disorder (OCD). The treatment of this condition is difficulty and a large percentage of patients fail to respond to medications and have residual symptoms. Such patients are referred to as having treatment resistant OCD.


Condition Phase
Obsessive Compulsive Disorder
Phase 4

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Augment in Treatment-resistent Obsessive-compulsive Disorder: an Open-label Trial

Resource links provided by NLM:


Further study details as provided by Creighton University:

Primary Outcome Measures:
  • Acamprosate would be efficacious for SSRI resistant OCD symptoms [ Time Frame: Patients will be administered 12 weeks of Acamprosate. ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Acamprosate would improve anxiety, depressive symptoms and quality of life in OCD. [ Time Frame: Patients will be administered 12 weeks of Acamprosate ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: April 2006
Study Completion Date: October 2009
Primary Completion Date: October 2009 (Final data collection date for primary outcome measure)

Detailed Description:

A patient will receive study drug for about 12 weeks. Throughout the study, the study doctor, on best medical judgment, may gradually increase or decrease the dose of the study medication. The adjustments will dependent on the subject's response and whether the subject has side effects. Once the subject has completed treatment under this study, the subject may resume standard treatment for his/her obsessive compulsive disorder by their regular doctor.

  Eligibility

Ages Eligible for Study:   19 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Psychiatry clinic

Criteria

Inclusion Criteria:

  • Men and women between 19-55 years of age
  • have dx of OCD as determined by the structured clinical interview for DSM-IV axis 1 disorders
  • SSRI resistant patients with OCD
  • Subjects who are able to comprehend and satisfactorily comply with protocol requirements and have ability to read and write English.
  • Signed written informed consent prior to entering any study procedures.
  • Concomitant psychotropic medications permitted only if prescribed at stable dose for at least 1 month before screening visit

Exclusion Criteria:

  • Patients with concurrent DSM-IV diagnosis of delirium, dementia, amnestic and other cognitive disorders
  • Patients with concurrent DSM-IV diagnosis of mental retardation
  • Patients with concurrent DSM-IV diagnosis of lifetime schizophrenia and other psychotic disorders
  • Patients with concurrent DSM-IV diagnosis of lifetime bipolar disorder
  • Substance dependence or abuse (excluding nicotine) within 6 months prior to screening visit
  • Patients with score of less than 16 on Y-BCOS during screening.
  • Patients with history of intolerance or hypersensitivity to acamprosate.
  • Patients based on history or mental status exam have significant risk fo committing suicide.
  • Patients who are homicidal or violent.
  • Patients with severe renal impairment
  • Female patients who are pregnant or lactating
  • Subjects with history of psychosurgery for OCD
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00590642

Locations
United States, Nebraska
Creighton University Department of Psychiatry
Omaha, Nebraska, United States, 68131
Sponsors and Collaborators
Creighton University
Forest Laboratories
Investigators
Principal Investigator: Sriram Ramaswamy, MD Creighton University
  More Information

Publications:

Responsible Party: Sriram Ramaswamy, M.D., Creighton University
ClinicalTrials.gov Identifier: NCT00590642     History of Changes
Other Study ID Numbers: CMP-MD-14
Study First Received: December 11, 2007
Last Updated: November 27, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Creighton University:
obsessive compulsive disorder
OCD
treatment-resistant
SSRI

Additional relevant MeSH terms:
Obsessive-Compulsive Disorder
Compulsive Personality Disorder
Anxiety Disorders
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on July 22, 2014